Myo-inositol and Melatonin in Pre-menopausal Women

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-12-31

Brief Summary

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The purpose of this study is to determine whether myo-inositol and melatonin, or myo-inositol alone, or melatonin alone, are effective in normalizing irregular bleeding and anovulatory cycles in pre-menopausal women.

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Detailed Description

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Melatonin has produced a remarkable significant improvement of thyroid function, positive changes of gonadotropins towards reduced levels, and in some women a re-acquisition of normal menstrual cycle. Furthermore, an abrogation of menopause-related depression, amelioration of hot-flashes and improvement of quality and duration of sleep has been reported.

Myo-inositol is involved in several aspects of human reproduction. Elevated concentrations of myo-inositol in human follicular fluids appear to play a positive function in follicular maturity and provide a marker of good quality oocytes. Nevertheless its positive role in PCOS women is a consequence of a defect in the insulin signalling pathway (inositol-containing phosphoglycan mediators) that seems to be primarily implicated in the pathogenesis of insulin resistance

Conditions

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Pre-menopausal Irregular Cycles and Bleedings

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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